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CompletedNCT03535441Updated May 24, 2018

HMGB1 Release From Hemorrhagic Shock Patients

An observational study in Intensive Care Unit, Hemorrhagic Shock and Adult Disease, sponsored by Xingui Dai. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-24.

Sponsored by Xingui Dai · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
18
Ages
18 Years and older
Sex
All
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Study summary

It is reported that high mobility group box 1 (HMGB1), a non-histone nuclear protein, can serve as an alarmin with damage associated molecular patterns to activate immune responses in the early stages of hemorrhagic shock (HS). However, the origin of HMGB1 and how it is released following HS is poorly understood. In this study, we teased out this mechanism. We try to record the concentration of serum HMGB1 protein following HS in clinical patients.

Read the detailed description

The study was approved by the First People's Hospital of Chenzhou, Hunan, P.R. China. Consent was obtained from patients in their hospital course. Eighteen patients were enrolled for each group. In addition, Acute Physiological and Chronic Health Evaluation II (APACHE II) score was used to evaluate the severity and morbidity of HS patients Serial blood samples were collected at indicated time points on hospital admission for HS patients (0, 2, 4, 8, 24, and 72 h following HS). Levels of HMGB1 were detected by ELISA according to the kit manufacturer's instructions.

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Conditions studied

  • Intensive Care Unit
  • Hemorrhagic Shock
  • Adult Disease

Keywords

  • hemorrhagic shock
  • HMGB1
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In context

Shock

916 studies on the registry are indexed under Shock; 176 are open to participants now.

This study's enrollment of 18 is below the median of 91 across 346 observational studies indexed under Shock.

Browse Shock studies →

Lead sponsor

Xingui Dai is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

Healthy volunteers OR Hemorrhagic shock (HS) patients enrolled in ICU

Inclusion criteria

Hemorrhagic shock (HS) was defined as out-of-hospital systolic blood pressure (SBP) of 70 mmHg or less or SBP ranging 71 to 90 mmHg with a heart rate of 108 beats/min or more.

Exclusion criteria

Exclusion Criteria:

pregnancy, \<18 years old, more than 2,000 mL of intravenous fluids or blood before enrollment, hypothermia, drowning, asphyxia, burns, isolated penetrating head injury, time of call received by dispatch to study intervention longer than 4 h, known prisoners, and transfer from another hospital

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
18 participants (actual)
Patient registry
No

Groups and cohorts

  • voluteer group

    No treatment, only blood sample collection

  • hemorrhagic shock group

    HS was defined as out-of-hospital systolic blood pressure (SBP) of 70 mmHg or less or SBP ranging 71 to 90 mmHg with a heart rate of 108 beats/min or more. Exclusion criteria were pregnancy, \<15 years old, more than 2,000 mL of intravenous fluids or blood before enrollment, hypothermia, drowning, asphyxia, burns, isolated penetrating head injury, time of call received by dispatch to study intervention longer than 4 h, known prisoners, and transfer from another hospital

06

What researchers measure

Primary outcomes

  1. serum HMGB1 concentration

    the concentration of serum HMGB1 were progressively increased following Hemorrhagic shock

    Time frame: 24 hours following hemorrhagic shock

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Study locations

1 site
  • The First Hospital of Chenzhou
    Chenzhou, Hunan 450003, China
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References and documents

Publications

  • Rickenbacher A, Jang JH, Limani P, Ungethum U, Lehmann K, Oberkofler CE, Weber A, Graf R, Humar B, Clavien PA. Fasting protects liver from ischemic injury through Sirt1-mediated downregulation of circulating HMGB1 in mice. J Hepatol. 2014 Aug;61(2):301-8. doi: 10.1016/j.jhep.2014.04.010. Epub 2014 Apr 18. PubMed 24751831 ↗
  • Rabadi MM, Xavier S, Vasko R, Kaur K, Goligorksy MS, Ratliff BB. High-mobility group box 1 is a novel deacetylation target of Sirtuin1. Kidney Int. 2015 Jan;87(1):95-108. doi: 10.1038/ki.2014.217. Epub 2014 Jun 18. PubMed 24940804 ↗
  • Hwang JS, Lee WJ, Kang ES, Ham SA, Yoo T, Paek KS, Lim DS, Do JT, Seo HG. Ligand-activated peroxisome proliferator-activated receptor-delta and -gamma inhibit lipopolysaccharide-primed release of high mobility group box 1 through upregulation of SIRT1. Cell Death Dis. 2014 Oct 2;5(10):e1432. doi: 10.1038/cddis.2014.406. PubMed 25275593 ↗
  • Hwang JS, Choi HS, Ham SA, Yoo T, Lee WJ, Paek KS, Seo HG. Deacetylation-mediated interaction of SIRT1-HMGB1 improves survival in a mouse model of endotoxemia. Sci Rep. 2015 Nov 2;5:15971. doi: 10.1038/srep15971. PubMed 26522327 ↗

Individual participant data

Plan to share: Yes — Hemorrhagic shock (HS) is a pathologic process caused by insufficient perfusion in multiple organs, and usually initiates a systemic post-traumatic inflammation response. The resulting increased inflammation response may accelerate the multiple organ dysfunctions . Extracellular high-mobility group box 1 (HMGB1) was found to mediate inflammation during sterile and infectious injury and contributes significantly to disease pathogenesis. However, the exact role of HMGB1-mediated inflammation in HS is not fully understood. In this study, we first test the serum HMGB1 concentration in clinical HS patients and then we explored the underlying mechanism in HS animal model. An unexpected mechanism of HMGB1 released from multiple organs (especially in kidney) was found.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03535441
Lead sponsor
Xingui Dai
Responsible party
Xingui Dai (serum HHMGB1 concentration of hemorrhagic shock patients, First People's Hospital of Chenzhou) — Sponsor-investigator
First posted
May 24, 2018
Start date
May 17, 2017
Primary completion
Apr 11, 2018
Completion
May 11, 2018
Last update
May 24, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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